1. Field of the Invention
The present invention relates to devices for testing the effectiveness of sterilization procedures and more particularly to process challenge devices using Biological Indicators to test the effectiveness of various sterilization procedures as the same are used to sterilize elongated objects.
2. Description of the Prior Art
Industries, including medical device manufacturing, health care, food packaging/preparation, and others, frequently require the sterilization of instruments and other objects. Sterilization procedures used in these industries may include steam, ethylene oxide gas, ionizing radiation, dry heat, hydrogen peroxide, chlorine dioxide, peracetic acid, ozone, plasma, and other related procedures.
The Association for Advancement of Medical Instrumentation (xe2x80x9cAAMIxe2x80x9d) has published recommendations for testing steam and ethylene oxide sterilizers. Several forms of test packs containing Biological Indicators and other materials have been developed to challenge the parameters necessary for such sterilization. The AAMI defines Biological Indicators as a calibration of microorganisms of high resistance to the mode of sterilization being monitored, placed in or on a substrate, packaged to maintain the integrity of the inoculated substrate in a manner convenient to the ultimate user, which serve to demonstrate that sterilization conditions were met. For purposes of the present application, the foregoing general definition of Biological Indicators shall be adopted.
Current Biological Indicators are constructed to test the effectiveness of a sterilization procedure on elongated objects, such as tubing, at either the beginning or at the end of the tube only. This is simply due to the fact that most Biological Indicators simply cannot be placed into the center of a length of tubing due to size restrictions. Commonly used Biological Indicators are too large to fit into the narrow lumens of most sizes of tubing. A Biological Indicator is to be placed within the object being sterilized and can thus test the effectiveness of the sterilization process at that particular location. However, none of the Biological Indicators presently used are capable of testing the effectiveness of the sterilization process in the actual center of a length of tubing. Any Biological Indicator is only capable of testing the effectiveness of the sterilization process at the point where the Biological Indicator can be placed or located. Accordingly, when the testing device cannot locate the Biological Indicator at different points along the length of the catheter to be tested, one cannot be reasonably certain that the sterilization process being used will sterilize the full length of the tubing, including the center of the tubing length, which can be the most difficult area to sterilize.
What is needed is an in-line process challenge device for testing the effectiveness of a sterilization procedure on elongated structures, such as tubes, at select points along their length.
The process challenge device of the present invention is provided for use in testing the effectiveness of various sterilization procedures. In its preferred embodiment, the device is comprised of two substantially similar end portions, each having an open tapered end and an opposite end that is provided with a coupling flange. The coupling flanges of the two end portions are operatively connected to one another using a system of locking tabs and receptacles that are formed on the coupling surface of flanges. The tabs provide a connection that must be broken in order to separate the two end portions. Once separated, the two end portions cannot be rejoined, thus creating a single-use device.
When the two end portions are coupled to one another, the tapered openings in the two end portions are connected by an open pathway that extends through the process challenge device. An enlarged chamber is provided within the pathway, intermediate the tapered openings, to receive a Biological Indicator.
In use, the tapered end portions of the device are ideal for receiving the ends of tubing of various diameters. Accordingly, where it is desirable to test the efficiency of a sterilization process in the middle of a piece of tubing that is to be sterilized, a length of tubing can be severed into two pieces at the location to be tested. The two pieces of tubing are then connected to the tapered ends of the Biological Indicator. The sterilization process is then initiated, allowing the sterilant to proceed through the ends of tubing into the tubing""s center area where the process challenge device is located. After the sterilization cycle is complete, the Biological Indicator can be aseptically removed from the device and incubated to determine whether sterilization was achieved at the location tested.
It is therefore a principal object of the present invention to provide an improved device for testing the efficiency of a sterilization process on elongated objects such as tubing.
A further object of the present invention is to provide an improved process challenge device for testing the efficiency of a sterilization procedure through the use of an xe2x80x9cin-linexe2x80x9d design.
Yet another object of the present invention is to provide a process challenge device that is capable of testing the efficiency of different sterilization procedures on various objects.
Still another object of the present invention is to provide a process challenge device for testing the efficiency of sterilization procedures using various forms of Biological Indicators.
Yet another object of the present invention is to provide a single use process challenge device for testing the efficiency of sterilization procedures on objects used in the medical device manufacturing, health care, or food preparation/packaging industries.
A further object of the present invention is to provide a process challenge device that protects the Biological Indicator from possible post-sterilization contamination from the time the process is complete to a later time when the Biological Indicator is cultured for growth/no growth testing.
Still another object of the present invention is to provide a process challenge device that is reasonably easy to manufacture and use.
These and other objects will be apparent to those skilled in the art.